The Food and Drug Administration will soon examine data to determine emergency use authorization for the Pfizer COVID-19 vaccine for children between the ages of 5 and 11.
“The government prioritizing it, the company prioritizing it and the community advocating for it makes it happen faster,” said Dr. Joseph Domachowske, one of the leaders in the pediatric trials.
In a statement on Monday, Pfizer-BioNTech announced its vaccine produces a strong immune response in children between the ages of 5 and 11.
This immune response data was gathered one month after the second dose was distributed to trial participants. The efficacy rate in this age group is not yet officially determined, but the group’s antibody response was comparable to fully vaccinated adults.
“So the presumption is that if these antibody levels are similar or higher that the protection, the real efficacy, will be in that same range,” Domachowske said.
Only a third of the vaccine amount given to adults was administered to young participants, and as a result, there was a lesser chance for side effects like fever and chills. A more severe but rare side effect of muscle inflammation was not found in any participants.
“It’s possible, but one of the reasons a lower dose was selected was to reduce side effects, and that may make that possible side effect go away completely after vaccinating millions of people,” said Domachowske.
He said that while Pfizer is prepared to present preliminary data to the FDA, the likelihood of children getting vaccinated by Halloween is unlikely.
He says the company will likely submit its application for emergency use authorization this week, but between the FDA poring over the data, going back to the company with questions and then making the final determination, the process will take weeks.
Domachowske is confident that children will be able to get vaccinated by Thanksgiving.
As for hesitancy, he says vaccine opinions are polarizing, but being unvaccinated puts others at risk.
“I’ll be first in line about mandates if this continues going on as it is because I think it’s dangerous for public health,” he said. “And I think it’s irresponsible to have something this safe and effective, and not use it.”
He says it’s important to remain patient because kids won’t be getting vaccinated overnight.
